510(k) K842687

BIOMEDICS BLADDER SCANNER by Biomedics — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1985
Date Received
July 10, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type